TOKYO, September 20, 2018 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced that roxadustat, an inhibitor of hypoxia ¬inducible factor (HIF) prolyl hydroxylase activity, met its primary endpoints in the Phase 3 ALPS study by demonstrating superiority in efficacy versus placebo in terms of both hemoglobin (Hb) response rate in the first 24 weeks and Hb change from baseline at Weeks 28 to 521. The preliminary safety analysis for this trial shows an overall event profile consistent with the results seen in previous roxadustat studies in CKD patients with anemia.
“The ALPS study adds to the growing body of evidence to support roxadustat as a potential treatment of anemia associated with CKD,” said Salim Mujais, M.D, senior vice president and global therapeutic area head, Medical Specialties Development, Astellas. “This condition can have a debilitating impact on the patients affected, and we look forward to continuing our work to potentially make a new therapeutic option available to the physicians who care for them.”
The ALPS study is the first of three Astellas Phase 3 studies conducted mainly in EMEA to report. The study forms part of a wider large-scale global Phase 3 development program for roxadustat conducted in collaboration with its partner FibroGen, Inc. (NASDAQ: FGEN), and will ultimately support filing and reimbursement in Europe. The ALPS study is a randomized, double-blind, placebo-controlled study of the efficacy and safety of roxadustat for the treatment of anemia in CKD in patients not on dialysis2.
Further detailed data from this study are expected to be reported in the future.
Sep 20, 2018